BONESUPPORT HOLDING AB

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Q4 FY2025 · Earnings Call TranscriptFebruary 24, 2026

Operator

Welcome to BONESUPPORT Year-End Report 2025 presentation. For the first part of the conference call, the participants will be in listen-only mode.

During the questions-and-answers session, participants are able to ask questions by dialing pound key 5 on their telephone keypad. Now, I will hand the conference over to CEO Torbjörn Sköld and CFO Håkan Johansson.

Please go ahead.

Torbjörn Sköld

Thank you, operator, and welcome, everyone, to BONESUPPORT's Q4 and full-year 2025 results call. My name is Torbjörn Sköld.

I'm the CEO of BONESUPPORT, and with me here today is our CFO, Håkan Johansson, and together, we will use the next 25 minutes to guide you through the Q4 presentation and then open the line for questions. Before we start the presentation, I would like to draw your attention to the disclaimers covering any forward-looking statements that we will make today.

Let's look at the financial and operational highlights from the quarter. Q4 was another strong quarter with solid execution across the business.

Net sales came in at 313 million SEK, corresponding to a growth of 22% versus Q4 2024. Sales growth at constant exchange rates was 36%, showing that there was a continued strong currency impact on our figures for the quarter.

Our adjusted operating results, excluding incentive program effects, was 81 million SEK, corresponding to an adjusted operating margin of 26%. Reported operating results was 82 million SEK, and we saw solid cash generation with operating cash flows reaching 54 million SEK.

We continue to see strong traction for CERAMENT G in the US, where both new accounts and increased use among current users contributed to the strong progress. CERAMENT G sales in the US reached 207 million SEK for the quarter compared to 154 million SEK in the same period the year before.

In Europe and rest of the world, we saw strong momentum, which more than offset the negative effects of the German market reforms. During the quarter, we also advanced our regulatory pipeline.

As communicated in early December, the FDA submission for CERAMENT V has now been transferred from the 510(k) pathway to the De Novo process. This change reflects the FDA's assessment that CERAMENT V may constitute an entirely new product category, like CERAMENT G in 2022, and positions us for stronger long-term market entry.

In addition, we initiated the early-stage launch of CERAMENT BVF for spine in the US, an important step as we continue expanding our portfolio of indications and applications. I will come back to that later in my presentation.

Now, let's move to the sales development. The chart shows total last 12 months reported sales in Swedish krona by quarter since 2019 in stacked bars per region and product category.

As you can see, the launch momentum for CERAMENT G in the US is exceptionally strong. Given that we keep bringing new strong clinical studies and opening up new markets, market segments, and new indications, a product like CERAMENT G will remain in launch phase for many years to come.

However, throughout 2025, we have seen strong influence from the US dollar to Swedish krona depreciation. Last 12 months growth in Q4 of 31% in the graph corresponds to an even stronger 40% at constant exchange rates.

Most of this quarter-over-quarter slowdown in last 12 months sales is due to a strong currency impact. US CERAMENT BVF last 12 months was flat year-over-year in constant currency.

In total, antibiotic-eluting CERAMENT grew with 54% last 12 months in the quarter in constant currency. Next slide, please.

In US, sales amounted to 259 million SEK, representing a growth of 40% at constant exchange rate. There was some general variability during the quarter due to the number of working days.

At the same time, we continue to experience strong growth of CERAMENT G, driven by both increased access through new accounts and new surgeons as well as wider adoption among existing accounts and surgeons. In trauma, we see expanding access and adoption in Level 1 trauma centers, which is an important validation of CERAMENT G for treating complex infections and bone voids in the most demanding clinical environments.

There are roughly 250 Level 1 trauma centers in the US. These are the very large and most important centers for advanced trauma treatments.

At the end of 2024, we had sold CERAMENT to 15 of these. At the end of 2025, we had sold to more than 140 Level 1 trauma centers.

That said, actual use is evolving gradually as trauma surgeons carefully assess and evaluate new products before they become part of regular use. Remember that full healing and evaluation of a trauma patient can take more than 6 months.

As part of our mission to modernize an outdated standard of care in the US, we have successfully opened one market segment after another. We started in foot and ankle, followed by trauma, and now moving into revision arthroplasty.

Interest continues to grow for CERAMENT G in revision arthroplasty and periprosthetic joint infections, two areas where the clinical needs remain substantial and where the evidence supporting our antibiotic-eluting technology has resonated strongly with surgeons. We've built a solid foundation for our spine strategy over the past quarters by establishing distributor coverage and preparing for the market.

In Q4, we initiated the early-stage launch of CERAMENT BVF in spinal procedures, with distributors now actively engaging spine surgeons across both existing and new partnerships. As this is a new clinical segment for us, more clinical data is needed to support broader market penetration longer term.

Importantly, the performance of CERAMENT BVF in spine will help confirm the value proposition for the CERAMENT platform, which will pave the way for the future CERAMENT G launch. We have made strong progress in evaluating and preparing the regulatory pathway, and we will share more on the path forward at our Capital Markets Day this spring.

Now, let's turn to Europe. Next slide, please.

Sales in Europe and rest of the world came in at 54 million SEK, representing 18% growth at constant exchange rates. Sales in Europe continued to be influenced by the same dynamics as observed in Q3, meaning that hospital reforms and surgical protocol programs in Germany were still impacting our sales.

However, direct markets, excluding Germany, delivered at normal growth rates. By the way, when we say normal growth rates, we mean normal for CERAMENT.

The growth rates that we see outside Germany are 4-5 times higher than growth rates for the market in general. Furthermore, hybrid markets in Southern Europe, Australia, and Canada are performing strongly.

We see positive traction from the investments made during the first half of 2025 reflected in improved sales performance. Now, I'll leave a deep dive into the numbers to Håkan.

Håkan Johansson

Thank you, Torbjörn. Net sales improved from 257 to 312.5 million, equaling a growth of 22% reported sales growth or 36% in constant exchange rates.

Torbjörn has already spoken about the solid performance in especially the US and the main drivers behind the sales growth, but as the weak US dollar somewhat hides a continue strong trajectory in the US, I would like to share the US sales performance in US dollars. CERAMENT G is the growth driver in the US, and this slide shows the quarterly CERAMENT G sales in the US in US dollars with continued solid performance quarter to quarter.

The number of working days in each period impacts sales, especially in Q4, which is impacted by both Thanksgiving and the holiday season over Christmas and New Year's. Taking this into consideration, a strong net sales per working day is noted during the quarter when looking at the orange line in the presentation.

The contribution from the US segment improved by 30 million and amounted to 120.2 million. The improved contribution relates to increased sales after effect from increased costs.

Selling and marketing expenses during the quarter amounted to 128 million compared with 108.8 million previous year, of which sales commissions to distributors and fees amounted to 85 million compared with 69.6 million the same quarter last year. From the graph at the bottom of the screen showing net sales as bars and gross margin as the orange marker, it can be noted that the gross margin remains stable and strong at around 95% with a minor decline in the period following a gradual impact from US tariffs.

In Europe and rest of world, a contribution of 11.9 million was reported to be compared with 12.8 million previous year. Selling and marketing expenses increased by 4.9 million, including 3.6 million related to the previously communicated commercial investments in the so-called EuroBooster program.

From the lower graph and orange marker, a minor drop in gross margin can be noted, mainly impacted by the market mix. Selling expenses, excluding sales commissions and fees, increased by 8.6 million, mainly in staffing expenses, of which 3.6 million relates to the so-called EuroBooster.

The increase from Q3 this year relates to seasonality as Q4 is usually intense in terms of congresses and marketing activities. R&D remain focused on the execution of strategic initiatives, such as the application studies in spine procedures and the market authorization submission for CERAMENT V in the US.

The expense for the quarter includes submission fees and other additional expenses related to the change in regulatory pathway for CERAMENT V in the US. Finally, administrative expenses, excluding the effects from long-term incentive programs, reports a small increase for the period, of which 2.8 million relates to the CEO succession.

The reported operating result amounted to 81.8 million despite unfavorable currency effects totaling 2.9 million, and I will come back to this in a later slide. The newly introduced tariffs in the United States had a gradual impact on costs in the quarter.

The full effect of the current 15% tariff will equal a 0.8% impact on US gross margins, which will come gradually with full effect late 2026. The difference between adjusted and reported operating results are costs regarding our long-term incentive programs, amounting to a negative expense of 0.5 million in the quarter compared with an expense of 13.7 million previous year, as you can see from the previous slide.

The reduced costs are due to the drop in share price. Operating cash flow remains solid with an increase in accounts receivables at the end of the year, mainly as customer payments seem to have been deferred to after the holidays.

During the period, the Swedish krona has continued to strengthen against the US dollar. Other operating income and expenses therefore contain foreign exchange gains and losses from the translation of the group's receivables and liabilities in foreign currency, amounting to a negative 2.9 million.

The graph on this slide shows with gray bars how the relationship between the US dollar closing rate and the Swedish krona has varied over time. This is read out on the right y-axis.

The blue dotted line read out on the left y-axis shows adjusted operating result. The adjusted operating result, excluding translation exchange effects, is the orange line and gives a more comparable view on the underlying trend in operating result.

In the table below the graph, you can see the FX-adjusted operating margin of close to 27% in the period compared with 22.6% in the same quarter last year. With this, I hand back to you, Torbjörn.

Torbjörn Sköld

Thank you, Håkan. To summarize Q4 2025, sales grew by 36% in constant currencies, reflecting steady and consistent progress.

Adjusted operating margin reached 26%. Cash flow also remained robust, underscoring the strength and scalability of the business.

I'm convinced that the most exciting part of our journey still lies ahead. As said, to provide a clearer view of what that journey will look like, we will host a Capital Markets Day in Stockholm on the 26th of May this year, which you are of course all welcome to join.

Now, happy to open up the line for questions.

Operator

If you wish to ask a question, please dial pound key 5 on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key 6 on your telephone keypad.

The next question comes from Viktor Sundberg from Nordea. Please go ahead.

Viktor Sundberg

Yes. Hi, and thanks for taking my questions.

I had a first one on CERAMENT G in the US. As you mentioned, year-over-year growth in the quarters are decreasing, but it's mostly FX-related, as you mentioned.

When you say mostly, is it anything that indicate any, let's say, underlying headwind in the US in 2025? Also what kind of underlying growth have you baked into your guidance for 2026, and how does that growth compare to 2025 growth in constant exchange rates?

That's my first question. Thanks.

Håkan Johansson

Thank you, Viktor. I think that the takeaway from the report is two.

One is, again, we see a continued strong trajectory with CERAMENT G in the US, especially when looking at sales in average per working day. Taking that in combination also what Torbjörn mentioned in terms of access to Level 1 trauma centers, etc., and of course both these aspects are aspects that's been included in our estimates and our work ahead of presenting the guidance for 2026.

We remain very optimistic on the continued opportunities for CERAMENT G in the US.

Torbjörn Sköld

Indeed. I would like just to add to that.

When we look at the performance in '25 and in Q4, we look at two important aspects of where the growth comes from in general and also particularly in CERAMENT G. It relates to new accounts, calling access, as well as increasing the adoption within existing accounts.

Both to those two levers, independent of whether it's on surgeon level, account level, IDN level, or GPO level, we measure that and track it. What's important for us is to make sure that we have a healthy growth not only in access and not only in adoption.

We want to have it in both. What we've seen throughout '25, as well as in quarter four, is that we have a really healthy adoption, and the growth rate on the total stems from both of those legs contributing almost to an equal size, which is very positive.

That goes generally as well as for CERAMENT G. On CERAMENT G in particular, we've already talked about the Level 1 trauma center adoption rate.

In '24, we sold to 15 of them, and in '25, we have sold to more than 140. With what we mean with sell is that we sell at least one product.

Again, it's very, very early phase. It's a really strong indication for us at least that we get access, we get interest among orthopedic surgeons, among the infectious disease doctors, and we have a really strong foundation to build on in trauma for many, many years to come.

That's on trauma. The next segment that we just about or just started to scratch the surface on is revision arthroplasty.

Early days. We have very convincing evidence, but it's a pilot study from Charité indicating very strong results for CERAMENT G in a revision arthroplasty segment.

This also looks very promising for both the short, medium, and long term in the US. On top of those parts, meaning trauma and revision arthroplasty, we have foot and ankle, which we still see a lot of potential to continue to build on as we develop more application techniques, as we come out with more clinical studies.

Then of course, very exciting for us is when we get FDA approval for CERAMENT V. We transitioned from a 510(k) process to a De Novo process, which longer term is actually very positive for us.

That of course adds to the total mix. We do not expect a lot of cannibalization on CERAMENT G from CERAMENT V.

We believe that that's going to be somewhat immaterial in the grander scheme of things. I think that paints the picture of our outlook short, medium, and long term for CERAMENT G in the US.

Viktor Sundberg

Thanks. Maybe in Germany and UK also that's been a bit of a drag on growth in '25.

How much of this drag is baked into your guidance for 2026? When do you expect this to turn around, and any sense of what the underlying demand is if funding issues would be a bit better in these countries?

Thanks.

Håkan Johansson

We communicated already when releasing Q3 that we do not expect a swift, call it, recovery in Germany. We think that Germany will remain somewhat sluggish throughout 2026.

However, when it comes to UK, and part of that we also saw in Q4, is that we expect the situation in the UK to normalize in the sense that surgeries where CERAMENT is used is coming back to normal levels. The surgical backlog in the UK is still large, which means that there will be also periods where we see a bit two steps forward, one step back, etc.

Again, we have seen gradual improvements, Q4 confirmed that, etc. We remain optimistic when it comes to the UK.

Viktor Sundberg

That's all for me. Thanks.

Operator

The next question comes from Erik Cassel from Danske Bank. Please go ahead.

Erik Cassel

Hi, morning, everyone. First, of course, everyone cares about the CERAMENT G US number and what that was organically.

If I've pulled the data correctly, it looked like it was up 55% organically, and that we have a USD number that was what was it, 21.9 essentially. Could you give any more detail on that sort of number if I'm correct in that assumption?

Because that would imply an FX rate of -21%. Thank you.

Håkan Johansson

Again, largely, the numbers could be recognized. We're not sharing the exact dollar numbers as that, because we're reporting in Swedish krona.

As we share in the presentation, you have both the absolute numbers in US dollar sales and also the average sale per working day. Again, as communicated, here we see a continued very strong and solid trend.

Erik Cassel

The 55% organic, that seems reasonable to you, you think?

Håkan Johansson

Again, if you just look at it from Q3 to Q4 in US dollars and not taking work days in consideration, it is a small growth in Q4 to Q3.

Erik Cassel

I'll leave it there. Could you maybe talk a bit on what sort of indications that happen to grow, let's say, faster than the overall CERAMENT G sales in the US, and which indications may be lagging that growth rate a bit so we sort of can understand what's driving this going forward?

Torbjörn Sköld

Yeah. I think if we look at the US and CERAMENT G sales only, and if we look at the three segments that we are in today and actively sell into, foot and ankle of course is the segment where we have been the longest period of time.

That's where BONESUPPORT started really. Still, both in absolute as well as in relative terms, an important contributor to the growth of CERAMENT G.

Given the size of it and given that we've been there for a number of years, it's further on in its life cycle, to say. Second is trauma, and here of course relatively new segment.

You saw the numbers in terms of access, so that's clearly a segment that will continue to drive growth rates both short and medium term, we're very bullish about trauma as well as we are on revision arthroplasty. I think you can sort of relate how long we've been in the respective segments to how much relative growth rates we can expect from them.

Having said that, all three segments are very important in absolute terms for us short and medium term. Just to be totally transparent and perhaps obvious to several of you on the call, CERAMENT G for spine is not yet approved in the US and will therefore not drive any growth in the short term, but longer term, we expect CERAMENT G, once it's approved and launched in the US for spine, to be an important segment also in parallel to the three segments that we're already in.

Erik Cassel

Thank you. Should I read that as the osteomyelitis indication being a bit more matured, maybe not growing as much right now?

Torbjörn Sköld

I wouldn't read that into it. Osteomyelitis is actually an indication that can happen in foot and ankle, it can happen in trauma, and also technically can happen also in revision arthroplasty.

I wouldn't draw that conclusion. Osteomyelitis is an underserved indication with a lot of unmet clinical need where CERAMENT G and V play an important role, I would not draw that conclusion that we've reached the saturation or maturity on osteomyelitis in general.

It's a very healthy and fast-growing segment for us.

Erik Cassel

Thank you. Then I just have a question on commission rates.

They sort of hit a new low here in this quarter. Does that sort of imply that fewer and fewer distributors are hitting their sort of bonus quotas?

If that's the case, could you maybe share a bit on sort of what's required for them to get to that sort of I guess 35% commission rate, which was I think high, and the sort of normalized lower? What's the difference there, and how much they need to sell and grow their accounts to get different bonus levels?

Håkan Johansson

A good question, Erik. Sounds like an area for clarification, because again, the line is defined as commission and fees and involves everything from commission to the distributors, GPO fees, credit card charges for the customers paying by credit card, etc.

It's the combination of these that is down a few percentage points. It's small movements in percentage of sales.

Commission remains relatively stable around 30%. The commission are included certain incentives if the distributors are exceeding their so-called quotas substantially, but we see very little movement in the average commission rate to sales.

The reason why it's down a few percentage points more relates to the other aspects of fees.

Torbjörn Sköld

To that, in terms of the distributor turnover, it's part of the beauty of the model that we have in BONESUPPORT in the US is that we want distributors to be on the journey with us. We want them to share the same goals.

We actively add new distributors, and when we have distributors that are not performing in line with the targets and goals and principles that we set, we don't hesitate to phase them out. Turnover among distributors we've always had, we will continue to have that, but as Håkan said, that is not one of the reasons why we see lower commission rates, on the contrary.

Erik Cassel

Thank you. Just the last question.

Far, we saw that sort of surgical volumes per day was up a bit in Q4. Can you say anything on the sort of pace that has been now through January and February if we're seeing the daily averages being roughly the same, increasing, just so we can think about the Q1 number we could expect?

Torbjörn Sköld

Yeah. No, thank you for the question.

We don't comment on Q1 as you know. Similar to we got a lot of questions on Q4 when we released Q3.

We feel confident in the journey that we're on. We feel confident in the guidance that we have said, indicating that we should grow in constant exchange rates at least 35%.

If we see any reason to change that, we will communicate it adequately and accordingly.

Erik Cassel

All right. Thank you very much.

I'll jump back in queue.

Operator

The next question comes from Mattias Vadsten from SEB. Please go ahead.

Mattias Vadsten

Hello, good morning. I have a couple of questions as well.

First one, what you shared there regarding Level 1 trauma centers, 140 versus 15 end of 2024. Just if you could share some color on how important this has been whilst establishing the sales guidance for '26, and of course, also interesting to hear some insights on adoption rates in sort of early-won Level 1 trauma centers as well.

That's the first one.

Torbjörn Sköld

Sure. Starting with your first question around the guidance of 35%, more than 35% growth in constant exchange rates.

We have also communicated that we expect CERAMENT V to be approved by the FDA around mid this year. Of course, if we get an earlier approval and we launch earlier than that, then of course we will distance ourselves or we expect to distance ourselves more on the upside versus the 35%.

However, let's say that we get late approval or no approval, then we will of course be close to the 35%. I think that's important to just point out that that's the role of CERAMENT V.

Now, when we did the guidance for '26, there's not only one factor of course that we take into account. We look at growth potential across the geographies.

We look at the growth potential of the different segments. Trauma in the US is an important segment for us, and the data point that we have on the Level 1 trauma centers is an important data point, as there are others as well in foot and ankle, in revision arthroplasty, in both US as well as Europe and rest of the world.

What is very important for us, and we've said this before and it's important to continue to say that, it's the balance between access and adoption that is very important. We don't want to just only grow by getting new accounts.

We don't only want to grow by increasing the adoption in existing accounts. We want to have a healthy balance between the two.

That's also a very important factor when we put the guidance together. Another also very important factor is when we simply, again, recalculate the penetration, meaning that the number of surgeries that we are in by geography, by market segment versus what we think is a realistic or longer-term outlook.

We still believe that we have a long runway to get to what we think are perfectly realistic penetration levels. I think, Mattias, it's not just the trauma number, but it's an important factor and combined with many other factors as I just described.

Mattias Vadsten

Good. Are you happy with what you see in terms of adoption in the Level 1 trauma centers that you won early days?

Torbjörn Sköld

Yes. Very happy.

Mattias Vadsten

Good. Then I just have a follow-up on the revision arthroplasty segment that you discussed here in the presentation, which was good.

Your position here, and maybe how much work is yet to be done for BONESUPPORT in terms of evidence and so forth to be able to have an ideal position, call it, for a more material contribution and a, yeah, better sales pitch around the segment? That's my next one.

Torbjörn Sköld

Yeah. Very good.

It's early days for us in revision arthroplasty. We have a fantastic pilot study that came out of Charité as communicated last year.

The results from that couldn't have been better from a BONESUPPORT and CERAMENT point of view, showing excellent results. Again, it's a pilot study, and the number of patients is limited.

We're building on that study going forward. I think this is an area where we over several years will need to do a lot more, which is perfectly natural, and that's part of the BONESUPPORT approach to penetrate a new market segment, meaning that we always lead with evidence.

We know that our product is very innovative. It has unique capabilities in terms of its handling and in terms of how it elutes antibiotic.

We always lead with evidence. A lot more work remains to be done in revision arthroplasty on the evidence side, more specific evidence.

We're working on it. We have initiated new studies, and we will continue to initiate new studies in this field.

However, orthopedic surgeons in general, they understand the unmet clinical need in the space of revision arthroplasty, where typically you face two challenges. Number one, how do you heal the bone?

How do you make sure that you grow bone in areas where you, for example, have bone voids as a result of explanting the implants in a revision situation? Having to deal with bone voids is normal, and it's standard for revision arthroplasty surgeon.

We have a great solution for that with CERAMENT. Also, infections in revision arthroplasty is one of the key reasons why primary implants need to be revised, because the patients have infections.

Dealing with infections is also high on the agenda of the revision arthroplasty surgeons. There, with CERAMENT G and V in Europe and hopefully when we get the approval for V in the US, we have a very, very intuitive solution that we already see now surgeons are willing to try and test.

Some of them surgeons are actually already use it as part of their standard routine. Several surgeons want to wait until we have more evidence.

Nothing is stopping us to enter this segment and penetrating this segment already now, but of course we need more evidence. In addition to that, we believe very much in specialization of our sales channels, meaning that a revision arthroplasty surgeon is not the same guy that does trauma, who is not the same guy that does foot and ankle.

We need specialization in our go-to-market channels. That's of course another aspect that we need to make sure that we get relevant sales channels, whether that's distributors as well as direct people, to go deeper in the respective market segments.

I hope that answers your question.

Mattias Vadsten

Absolutely. Good answer.

My last one is fairly quick. In terms of the working days that you discussed here, how many fewer working days was it Q4 vis-à-vis Q3?

Was it like 2 days or?

Håkan Johansson

It was 3 days shorter, if I remember, 3 or 4 days, but my memory is not skewing me, 3 days shorter.

Mattias Vadsten

Okay. Thank you very much.

Operator

The next question comes from Kristofer Liljeberg from Carnegie. Please go ahead.

Kristofer Liljeberg

Hi, good morning. Three or four questions.

The first one on this sort of sequential growth for CERAMENT G in the US per surgery day seems much stronger in Q4 versus pretty weak third quarter. Could you explain is there any particular reason for this or just natural swings between quarters?

Thank you.

Håkan Johansson

Again, as much as we referred to underlying natural swings quarter to quarter in Q3, that explanation remains in Q4. Because again, it's, as with forward-looking estimates, there are several parameters that is moving, and so on.

I don't see any specifics, and I'm looking at Torbjörn, but I think that we share that view.

Kristofer Liljeberg

Good. The better growth in Europe, would you say that's sustainable?

Just making sure that there is no positive, one-off, larger orders or anything this quarter explaining the much better growth in Q4 versus what we have seen previous quarters?

Håkan Johansson

Again, what was positive to see, Kristofer, was the improvement in the UK, to see what's been in our analysis to see that also realized. At the same time, we remain modest.

We have to remain modest, because again, as I mentioned in the call, the surgical backlog remains long in the UK. There could be short periods of swings back to a slower momentum and so on, and then swing back again, etc.

Again, I think we're remaining optimistic, good to see the improvements in Q4. When we look at the investment markets, I call it, we expect that momentum to continue when looking outside our direct markets, and the investments made in our so-called hybrid markets, Italy, Spain, Australia, South Africa, Canada, just to mention a few.

Again, there, we start from quite below penetration level, and there are so much market potential remaining in these markets. We believe that the investments done is a good way to capture that potential.

Kristofer Liljeberg

Good. Then my third question.

You mentioned the increased number of trauma centers that you are selling to. Still early days, but have you reached good adoption already at some of those centers, or is that also too early to see?

Torbjörn Sköld

No, clearly in some of them, but still it's a very small number where we have reached a solid adoption level. It's really early days, and again, the definition that we use here is that selling to, meaning that we've sold minimum one packet of CERAMENT.

Of course, some of them, early adopters that were early out, we have good adoption level, but not even close to what we think is the potential. Just do the math.

Most of these trauma centers that we've sold to are still very, very early in their journey. We'll keep ourselves busy to increase the adoption in these Level 1 trauma centers in the US.

Kristofer Liljeberg

Thank you. Then finally, just a clarification when it comes to guidance for 2026.

You have included, as it seems then, very little or no CERAMENT V sales in the guidance?

Torbjörn Sköld

That's correct. That's to be prudent, because we only know what we know, and although we have a great dialogue with FDA, you never know with FDA.

We follow their guidance, similar to what we did now in Q4 in terms of transferring CERAMENT V from a 510(k) to a De Novo. Although unexpected to us, we think it was a very good decision longer term for us.

It is important that we follow and deliver on what FDA wants us to. Of course, if we don't get CERAMENT V, we still believe that the 35% growth rate is definitely realistic, but it's going to be a lot easier to overdeliver if we get an early approval of CERAMENT V in the first half of this year.

Kristofer Liljeberg

Okay. Thank you very much.

Operator

The next question comes from Sten Gustafsson from ABG Sundal Collier. Please go ahead.

Sten Gustafsson

Yes. Thank you.

Good morning. A follow-up on the US market penetration and adoption.

I think to ask it in a different way, but I think in the past you have shared with us number of surgeons you have trained. I believe maybe I'm mistaken here, but the last number I have in my head is 1,000 surgeons.

I was wondering if you could update me on where you are today on that number.

Torbjörn Sköld

Yeah. No, good question, Sten.

Thank you very much. To put your question into context, this relates to all the sort of relevant surgeons in the fields that we're in today, excluding spine.

That relates to foot and ankle, trauma, and revision arthroplasty. The boring part of my answer is that no, we're not going to provide an update to that number.

We don't have that routine yet. When we have that routine and when we have updated numbers that we're willing to disclose, we will of course do that.

Having said that, we are not slowing down. We're putting our foot on the gas to accelerate, which I think we see from both the financial as well as the operational numbers, including that reference point around the major trauma centers, because clearly you don't really get access without training an orthopedic surgeon.

Sten Gustafsson

I understand. Those Level 1 trauma centers, on average, do they have like 50 or 100 different surgeons, or what was the size like?

Torbjörn Sköld

It of course varies. In total US as per our segmentation, we have 250 Level 1 major trauma centers.

If you're a major trauma center, you're not running around with only sort of five trauma surgeons. Then you're not a major trauma center.

It can vary, and I don't want to put a number out there, but there it could be anything from I would only be guessing, but they're quite a number of trauma surgeons on these different centers. Our ambition in the first place is to focus on the market segments of course where we focus on, foot and ankle and trauma, and then focus on the most complex, difficult cases within trauma where we see that CERAMENT G adds the most clinical value.

Then you typically start with one, maybe two surgeons and one ID doc. You start there, only one indication or one type of case, and then you expand from there.

That's a journey that honestly can take several years. Of course, we want to do it in the right way and make sure that we and our product adds value to not only the orthopedic surgeon, but also the hospital and the healthcare system.

Sten Gustafsson

Makes sense. My next question would be on BVF and spine in particular.

I notice a nice uptick or a change in growth trajectory for CERAMENT BVF in North America, and I was wondering how much of that is sort of quarterly variation and how much is related to spine?

Torbjörn Sköld

Given the fact that we initiated the launch in December on spine BVF, and we tried to keep it a very focused launch in Q4, I wouldn't draw any conclusions that it is the spine launch in the US with the CERAMENT BVF that sort of made that number look the way it looks. It's more normal variations.

Sten Gustafsson

Okay. Excellent.

My final question is India. What's the timeline looking like and what type of potential should we consider for India?

Torbjörn Sköld

Yeah. No, of course, no sales in Q4 for India.

When we look at India strategically long term, it's an attractive market for a couple of reasons. The main reason is it's a lot of people in India.

Second, there's a lot of people who are willing to pay for care in India. The approach that we take is a very focused approach on private payers and the hospitals that serve this patient population.

When we look at that patient population in terms of size, it's a sizable segment, very attractive longer term. What we see now in India, it's first early steps.

Longer term, give it a couple of years, it could be an important contributor for us, but most importantly, it's another growth leg to have in Europe and rest of the world because we say that a lot of times even in Europe and rest of the world, we're very, very early phase. We depend and have depended a lot on UK and Germany, and we've been painfully aware of that when we have had the market reforms in Germany.

Adding India is an attractive segment, but again, as with all countries, it will take time. If you count the total population and if you segment that population into how many of them do have private insurance and how many of them have access to certain private hospitals, we feel very confident about that number, and we expect sales to start in India already in first half of 2026.

Sten Gustafsson

Excellent. Thank you very much.

I'll get back into the queue.

Operator

The next question comes from Oscar Bergman from Redeye. Please go ahead.

Oscar Bergman

Hi, Torbjörn and Håkan. I just have three questions for you.

The first one, I think at US ambassador sites for bone infection, could you give sort of a ballpark figure of what percentage of relevant procedures are done with CERAMENT G today? Have they or have you become the de facto standard of care at some of the centers in the US?

Torbjörn Sköld

Great question. To answer that last part, I I would dare to say yes, but it's still only a a a relatively small number where we have genuinely become the standard of care.

Of course, because what what's the definition of standard of care? Do you only look at one patient indication?

Do you look at several, etc., etc.? I I think we're we're getting we're getting traction.

Clearly, one very important way to establish this for us is to look at our great collaboration with the Oxford Bone Infection Unit in the UK. We have a fantastic collaboration and partnership with them, and and one of the best ways we can educate patients in the US, oh, sorry, educate surgeons in the US is simply by sending them to Oxford and and see how they work with it.

We see great results, including that changing the standard of care, moving to more CERAMENT use in their daily practice. I would say yes, there are centers in the US that have changed their standard of care, but it's still very early days.

I don't have any hard data to to to to share.

Oscar Bergman

Okay. Do you know if those centers are typically university hospitals?

Torbjörn Sköld

Yeah. One of the key strategies in the US that we have and had for several quarters and potentially years is that we target academic medical centers.

That is simply because that's where they are very evidence- and research-focused, they actually pay a lot of attention to the evidence that we have. That one of the key pillars in our strategy is to invest in and promote and lead by evidence.

That sort of fits like a hand in the glove to that. Commercially, it's a really good way to sell and target academic medical centers because they train a lot of fellows that when they're done training and when they're done with their fellowships, they go to somewhere else.

They could go to a different academic medical center, or they could start their own practice or go somewhere else. Definitely, our products, it's very well in academic medical centers simply because it's much higher evidence level on our product than what's currently on the market.

Oscar Bergman

Okay. India was very, very interesting to hear about.

I assume that the regulatory processes there are piggybacking CE marks for CERAMENT G and BVF, right?

Torbjörn Sköld

Yeah. Of course we use the clinical data and we use the material that we've produced for US, that we've used for Europe.

India is a particular country and with a somewhat complicated process, but the team has done a fantastic job on that, and we're getting very close to starting to launch in India in the first half of 2026.

Oscar Bergman

Okay. Are there any other markets that you aim to launch at in the near to medium term?

I think we've spoken about Japan before. Very high level, of course, but would be interesting to hear about Japan.

Torbjörn Sköld

Yeah. Japan is still on the list.

It's a very attractive orthopedic market. Similar to India, somewhat complex regulatory pathway to enter in Japan, but we're actively working on it.

We've said that before also, there's no change in that strategy. We're getting closer to launch, but from a timing-wise, India will happen before Japan.

Oscar Bergman

Okay. You also mentioned some safety inventory and longer payment terms due to the holidays.

Is it a fair assumption then to make that your free cash flow conversion should normalize already in Q1?

Håkan Johansson

Again, I think that when you look at that, Oscar, it's key to see you have the accounts receivables, but you also have accounts receivables in combination with the so-called K sheets that is reported as accrued revenue. Part of the increase in accounts receivables in Q4 relates to a reduction in accrued revenue or open K sheets end of Q4 compared to Q3.

The rest is simply that payments has been deferred from December to after the holidays. With that, yes, we can expect to see the situation stabilize and normalize going into Q1.

Again, the balance sheet is measured on the clock on one day, there will always be volatility in a balance sheet. Over time, cash flow never lies.

Oscar Bergman

Yeah. Thank you.

Operator

The next question comes from Viktor Sundberg from Nordea. Please go ahead.

Viktor Sundberg

Yes. Thanks for allowing a follow-up here.

Just to follow up on your progress in trauma, one of the worries in the market with regards to trauma in the US has been that maybe surgeons do not always feel the acute need to prophylactically use infection prevention in surgeries with a product such as CERAMENT G that comes with a bit of a price premium to other products without infection prevention in contrast to osteomyelitis when the infection is already always present at intervention. Can you just comment on that as you have met more surgeons day to day at this Level 1 centers and have got their feedback if this is correct or not to look at adoption in trauma in that way?

Maybe also quickly the NTAP here, any more color on how the added NTAP for trauma and the dropped NTAP for osteomyelitis will impact US sales when we have moved a bit into 2026, and you might have gotten a bit more data on this dynamic? Thanks.

Torbjörn Sköld

Yeah. We'll start with the second question first for simplicity, and then we'll comment on the first one.

In Q4, we did not see any material impact, negative impact of the lost NTAP that actually came into effect 1st of October. We don't see that we lose volume due to that.

Again, early days, but in Q4, we didn't have any signals on that. I think to your point on trauma surgeons prophylactically or not, I think we need to start even more basic in trauma, meaning that actually when there is a very high risk of infection or actually that they have confirmed infection, that's where we start with in trauma.

I don't think that we've reached any maturity or saturation on that level. Once we've done that, then of course it comes to prophylactically.

Prophylactically of course is always more challenging than the starting point, but once you get the starting point right, my experience is at least that once you've get that right, you see and you get the surgeons to understand and see the value that CERAMENT has, then moving into that prophylactic stage becomes more natural. Different surgeons, different clinics, different centers are in different parts of this journey.

I would argue that still, prophylactically is further out, but we're making really good progress by starting with the basics and getting them to be aware and understand the role of CERAMENT G in these type of cases.

Viktor Sundberg

Thanks.

Operator

There are no more questions at this time, I hand the conference back to the speakers for any closing comments.

Torbjörn Sköld

No, with that, thank you all for your interest, and we wish you all a great rest of the day. Thank you.